FDA approved Vancomycin Injection for Septicemia, Endocarditis, and Other InfectionsFDA approved new version of vancomycin antibiotic for serious infections

FDA From the archive Source published February 15, 2019 Summary added August 21, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider vancomycin for MRSA and other susceptible gram-positive infections; use only when the entire dose is required.

The FDA has approved Vancomycin Injection (Tyzavan) for the treatment of serious infections caused by susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The approval covers septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections in adults and pediatric patients 1 month and older. This glycopeptide antibacterial provides a new formulation option for clinicians managing these challenging infections, particularly in patients with penicillin allergy or those who have failed other therapies.

The approval is based on the established efficacy of vancomycin, a well-known antibiotic. However, the label does not include specific clinical trial data for this formulation. Clinicians should note that this product is intended for intravenous use only and is formulated in single-dose bags to deliver the entire dose, which may reduce preparation errors. The recommended infusion time is 60 minutes or greater to minimize infusion-related reactions.

Vancomycin remains a critical option for MRSA and other resistant gram-positive infections. This approval reinforces its role in settings where oral antibiotics are not appropriate. As with all antibacterials, it should be used judiciously to limit the development of drug-resistant bacteria.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Vancomycin is a glycopeptide antibacterial that inhibits cell wall synthesis in susceptible bacteria. It binds to the D-alanyl-D-alanine precursor, preventing peptidoglycan polymerization and cross-linking, leading to bacterial cell death.

Indication & Patient Population

Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of: - Septicemia due to susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase-negative staphylococci, and methicillin-susceptible staphylococci in penicillin-allergic patients or those who cannot receive or have failed other drugs. - Infective endocarditis due to susceptible isolates of MRSA, viridans group streptococci, Streptococcus gallolyticus, Enterococcus species, and Corynebacterium species. For enterococcal endocarditis, use in combination with an aminoglycoside. Also indicated for early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside. - Skin and skin structure infections due to susceptible isolates of MRSA and coagulase-negative staphylococci, and methicillin-susceptible staphylococci in penicillin-allergic patients or those who cannot receive or have failed other drugs. - Bone infections due to susceptible isolates of MRSA and coagulase-negative staphylococci, and methicillin-susceptible staphylococci in penicillin-allergic patients or those who cannot receive or have failed other drugs. - Lower respiratory tract infections due to susceptible isolates of MRSA, and methicillin-susceptible staphylococci in penicillin-allergic patients or those who cannot receive or have failed other drugs.

Dosing & Administration

- For intravenous use only. Do not administer orally. - Use only in patients who require the entire dose (500 mg, 750 mg, 1 g, 1.25 g, 1.5 g, 1.75 g, or 2 g) and not any fraction thereof. - Administer by intravenous infusion over 60 minutes or greater to reduce the risk of infusion reactions. An infusion rate of 10 mg/min or less is associated with fewer infusion-related events. - Adult patients: 2 g divided either as 0.5 g every 6 hours or 1 g every 12 hours. - Pediatric patients (1 month and older): 10 mg/kg per dose given every 6 hours. - Patients with renal impairment: See full prescribing information for recommended doses. - Concentrations of no more than 5 mg/mL are recommended in adults. - Administer prior to intravenous anesthetic agents to reduce infusion-related reactions.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

- Obtain a pregnancy test in females of reproductive potential prior to initiating treatment. - Infusion-related reactions may occur at any rate or concentration; monitor patients during infusion. - Use only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce the development of drug-resistant bacteria. - No contraindications are listed in the label.

Place in Therapy

Vancomycin Injection is a key option for treating serious gram-positive infections, particularly MRSA, in patients who require intravenous therapy. It is especially valuable in penicillin-allergic patients or those who have failed other antibiotics. This formulation offers convenience with single-dose bags, but clinicians must ensure patients require the entire dose. As with all antibiotics, judicious use is essential to preserve effectiveness.

The U.S. Food and Drug Administration (FDA) has approved a new version of the antibiotic vancomycin, called Tyzavan. This medicine is given through a vein (intravenously) to treat serious infections caused by certain bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). It is approved for conditions like blood infections, heart valve infections, skin infections, bone infections, and some lung infections in adults and children aged 1 month and older.

Vancomycin has been used for many years, and this new formulation is designed to be given in single-dose bags. This may help reduce errors when preparing the medicine. The recommended infusion time is at least 60 minutes to lower the risk of side effects like flushing or itching.

This approval is important because vancomycin remains a key treatment for resistant infections, especially for people who cannot take penicillin or who have not improved with other antibiotics. However, it is not a new drug, and it does not mean that everyone with an infection should receive it. Doctors will decide if this medicine is right for each patient based on the type and severity of the infection.

If you or a loved one has a serious infection, talk to your doctor about the best treatment options. This approval adds another tool for doctors, but it is not a reason to change any current treatment without medical advice.

What this means for you:

Tyzavan is a new form of vancomycin for serious infections, but always follow your doctor's advice.

Study Details

Study typeFda approval

PublishedFeb 2019

View Original Abstract ↓

1 INDICATIONS AND USAGE Vancomycin Injection is a glycopeptide antibacterial indicated in adult and pediatric patients (1 month and older) for the treatment of: Septicemia ( 1.1 ) Infective Endocarditis ( 1.2 ) Skin and Skin Structure Infections ( 1.3 ) Bone Infections ( 1.4 ) Lower Respiratory Tract Infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. ( 1.6 ) 1.1 Septicemia Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of septicemia due to: Susceptible isolates of methicillin-resistant Staphylococcus aureus (MRSA) and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.2 Infective Endocarditis Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of infective endocarditis due to: Susceptible isolates of MRSA. Viridans group streptococci Streptococcus gallolyticus (previously known as Streptococcus bovis ), Enterococcus species and Corynebacterium species. For enterococcal endocarditis, use Vancomycin Injection in combination with an aminoglycoside. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of early-onset prosthetic valve endocarditis caused by Staphylococcus epidermidis in combination with rifampin and an aminoglycoside. 1.3 Skin and Skin Structure Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of skin and skin structure infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.4 Bone Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of bone infections due to: Susceptible isolates of MRSA and coagulase negative staphylococci. Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.5 Lower Respiratory Tract Infections Vancomycin Injection is indicated in adults and pediatric patients (1 month and older) for the treatment of lower respiratory tract infections due to: Susceptible isolates of MRSA Methicillin-susceptible staphylococci in penicillin-allergic patients, or those patients who cannot receive or who have failed to respond to other drugs, including penicillins or cephalosporins. 1.6 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Vancomycin Injection and other antibacterial drugs, Vancomycin Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

FDA approved Vancomycin Injection for Septicemia, Endocarditis, and Other InfectionsFDA approved new version of vancomycin antibiotic for serious infections

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

FDA approved Vancomycin Injection for Septicemia, Endocarditis, and Other InfectionsFDA approved new version of vancomycin antibiotic for serious infections

Study Details

Intrawound tobramycin plus vancomycin did not reduce deep infection risk compared with vancomycin alone in high-risk tibial fractures

Adding Antibiotics to Bone Surgery Didn't Lower Infection Risk

Clinical research that matters. Delivered to your inbox.

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